510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LDPClass II

Colorimetry, Acetaminophen

21 CFR 862.3030 / Clinical Toxicology
FDA source (opens on fda.gov)

LDP is the FDA product code for Colorimetry, Acetaminophen, a class II device type, regulated under 21 CFR 862.3030. As of , FDA records hold 37 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
LDP
Device name
Colorimetry, Acetaminophen
Regulation
21 CFR 862.3030
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
37
Ingested recalls
12

Clearances, product code LDP

By decision year
37 clearances under product code LDP with a decision year between 1980 and 2026, 1982 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LDP by decision year
YearClearances
19801
19823
19832
19842
19852
19882
19891
19901
19931
19953
19962
19982
19991
20002
20011
20022
20052
20061
20091
20101
20111
20191
20221
20261

Applicants with the most clearances

Product code LDP
Applicants holding the most 510(k) clearances under product code LDP
ApplicantClearances
Siemens Healthcare Diagnostics Inc.6
Sekisui Diagnostics P.E.I. Inc.6
Roche Diagnostics GmbH3
Abbott Medical2
Stanbio Laboratory2
Bayer Diagnostics Corp.1
Bio-Analytics Laboratories, Inc.1
Biosite Incorporated1
Clin Tech Diagnostics Corp.1
Dade Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order